SPINERY™ A Novel Radio-Frequency Tumor Ablation Device Study

Vertebral Metastasis Clinical Trial

— SPARTA  

Official title:

Clinical Study of SPINERY™ A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05467540
• Other study ID #: Protocol #2020-01
• Status: Recruiting
• Phase: N/A
• Start date: July 11, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2023
• Source: Axon srl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SPINERY is a Radiofrequency (RF) device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum.

In particular, SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies, sacrum, iliac crest and periacetabulum, in patients with indication for Standard Therapy and in patients who have failed, not candidates or refuse Standard Therapy.

Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term (3 months) pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors, without causing device-related adverse events including, in particular, nerve injury.

Primary objective hypothesis will be obtained with Brief Pain Inventory (BPI) scale performance questionnaire in terms of palliative treatment.

Change of Worst Pain Score expressed as average reduction of 2 BPI (Brief Pain Inventory) scores will be calculated as:

μc = worst-pain 3-month - worst-pain baseline

A negative average value for change in pain represents a lowering of the subject's pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject's pain score (a worsening or increase in pain). Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with painful metastatic malignant lesions involving bone;

• Patients, candidates to standard therapy, in which the RF ablation can be performed in combination with the Standard Therapy in accordance with the Investigator's indications;

• Patients who have failed, not candidates or refuse Standard Therapy (chemotherapy or radiotherapy);

• Patients with metastatic tumor size compatible with the expected ablation dimensions as reported for SPINERY devices in the IFU;

• Patients with localized pain resulting from not more than two sites of symptomatic metastatic disease

• Patients that do not have evidence of impending fracture

• Patients with metastatic lesions targeted for treatment located in the thoracic and/or lumbar vertebral body(ies), peri-acetabulum, iliac crest, and/or sacrum - no restrictions on location of lesion;

• Patients with BPI-Report worst pain score =4/10 at the target treatment site within the past 24 hours

• Patients with Karnofsky score = 40 at enrollment

• Patients willing and able to provide a signed and dated informed consent, comply with the study plan, follow up visits and phone calls

• Patients at least 18 years old at the time of informed consent

Exclusion Criteria:

• Patients implanted with heart pacemaker or other implanted electronic device

• Patients with previous mechanical bone stabilization in the vertebral body to be treated

• Use of SPINERY in vertebral body levels C1-C7

• Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index vertebra or bone.

• Active or incompletely treated local infection at the planned treatment site(s) and/or systemic infection.

• Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy or neurologic compromise.

• Planned treatment site(s) associated with spinal cord compression or canal compromise requiring decompression.

• Fractures due to prostatic cancer or other osteoblastic metastases to the spine. Metastatic lesions originating in the prostate that are osteolytic or of mixed origin are eligible for the study.

• Pregnant, breastfeeding, or plan to become pregnant during the study duration.

• Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.

• Any condition that would interfere with the subject's ability to comply with study instructions or might confound the study interpretation.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Vertebral Metastasis

Intervention

Device:
• SPINERY
Radio-Frequency device designed for palliative treatments of patient with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum

Locations

Country	Name	City	State
Italy	Ospedale Santissima Trinità	Cagliari
Italy	Istituto Oncologico del Mediterraneo IOM	Catania
Italy	Azienda Ospedaliera di Cosenza	Cosenza
Italy	Azienda Ospedaliera Antonio Cardarelli	Naples
Italy	Azienda Ospedaliera Universitaria Senese	Siena

Sponsors (1)

Lead Sponsor	Collaborator
Axon srl

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Worst Pain Score of Brief Pain Inventory (BPI) scale performance is being assessed	Change of Worst Pain Score expressed as average reduction of 2 BPI scores: Thoracic/Lumbar/ Peri-acetabulum/Iliac Crest/Sacrum RF Ablation	Baseline, 3 months
Primary	Completion (%) of the ablation procedure	Completion (%) of the ablation procedure without device-related adverse events including in particular nerve injury	Immediately after the procedure, 3 months